510(k) · Cleared

Cleared

Fresenius Ultraflux Hemodialyzer

K031378510(k) SpecialCleared May 30, 200329-day reviewClass II21 CFR 876.5860

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Fresenius Medical Care North America · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

Cleared on May 30, 2003 as substantially equivalent to K002277 (Fresenius Medical Care North America, 2000) after a 29-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.

Decided: May 30, 2003
Review: 29 days
Class: Class II
Product code: KDI
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K002277 (2000). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK002277 Fresenius Optiflux 200NRFresenius Medical Care North America · 2000 · Recalled
This deviceK031378 Fresenius Ultraflux HemodialyzerFresenius Medical Care North America · 2003
Descendant · cites it directly · 0 of its ownK034064 Fresenius Ultraflo HPX HemodialyzerFresenius Medical Care North America · 2004

Most influential descendants

Showing 1 of 1 · See all

K034064Fresenius Ultraflo HPX HemodialyzerFresenius Medical Care North America · 2004 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K002277	Fresenius Optiflux 200NR	Fresenius Medical Care North America	2000	6
0 (this device)	K031378	Fresenius Ultraflux Hemodialyzer	Fresenius Medical Care North America	2003	—
+1	K034064	Fresenius Ultraflo HPX Hemodialyzer	Fresenius Medical Care North America	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0

FIG. 1 — Lineage of K031378, 2000–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KDI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KDI device

#1 K243874 FX CorAL 60 (F00012969); FX CorAL 80…score 18.2 · 12 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K002277	Fresenius Optiflux 200NR	Fresenius Medical Care North America	2000	6
Kept off the family tree	K982414	FDA’s K982414 is Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ Hemofilters Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	Gambro Healthcare	1999	—

Also cleared against K002277: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K034064	Fresenius Ultraflo HPX Hemodialyzer	Fresenius Medical Care North America	2004	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K034064 (Fresenius Medical Care North America, 2004) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K002277.

How does its category compare?

All KDI devices

KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KDI

9in 2025

2007high 11 (2007) · low 2 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KDI

199in 2025

2007high 266 (2020) · low 69 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KDI

2in 2025

2007high 17 (2022) · low 0 (2008)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · KDI

2,786in 2025

2007high 6,154 (2014) · low 522 (2009)2025

MAUDE reports naming product code KDI, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	11	91	4	916
2008	6	148	0	1,042
2009	4	236	3	522
2010	9	186	1	823
2011	5	85	4	2,270
2012	6	153	1	1,765
2013	11	247	2	2,360
2014	8	164	3	6,154
2015	5	69	5	4,182
2016	5	230	4	766
2017	8	188	1	963
2018	2	—	1	1,716
2019	4	263	6	1,587
2020	9	266	0	1,633
2021	2	—	2	1,944
2022	7	259	17	2,180
2023	7	157	8 (8)	2,692
2024	7	235	4 (2)	2,441
2025	9	199	2	2,786
2026	6	154	2	—

What is it indicated for?

The Fresenius Ultraflux dialyzer is designed for single use acute and chronic hemodialysis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031378 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031378: Fresenius Ultraflux Hemodialyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031378

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026